ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians......................— ADIA Strategic Plan

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Minister’s Intervention On Medical Devices Fee Welcomed

29th Jun 18

Summary —

As a result of lengthy negotiations in Parliament House the Australian Government will work with ADIA to monitor how the new medical devices fee will be implemented in order to reduce the dental industry's compliance costs.

Key Issues For The Dental Industry —

Advocacy by the Australian Dental Industry Association (ADIA) has secured several important outcomes associated with the introduction by the Therapeutic Goods Administration (TGA) of a new fee to place low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG). The ARTG is the list of medicines and medical devices that can be lawfully supplied in Australia.

ADIA was concerned that the introduction of this new fee would adversely impact manufacturers and suppliers of innovative dental products. As a consequence, ADIA embarked upon a multi-faceted policy advocacy campaign to secure a review of the proposed fee.

The Minister for Health, the Hon. Greg Hunt MP, discussed the new fee with ADIA in mid-June 2018 and a subsequent meeting was held in the Minister's office to consider the matter. Joining this meeting were senior staff from the TGA. This meeting secured a commitment from the Minster’s office, ADIA and the TGA to continuing working cooperatively to implement the new application fee for low-risk medical devices and to support regulatory improvements through the review of low risk devices.

Recognising the concerns expressed by ADIA about how the fee will impact small businesses in the dental industry, the meeting in the Minister’s office secured a commitment of all parties to work in cooperation with stakeholders to monitor the implementation of the fee. There will also be improvements as to how the ADIA is consulted about future changes to TGA fees.

A TGA Working Group on low risk medical devices will be formed with ADIA to take a lead role in setting the agenda to help drive positive outcomes for the Australian dental industry.

Following the meeting, the Minister for Health wrote to ADIA expressing “the significant contribution small businesses provide to the Australian health system and economy and I am pleased to have addressed this matter in partnership with you”.

The Health Minister also thanked ADIA for its continued support for a robust regulatory system and that he appreciated the “constructive engagement on this matter and I look forward to continued engagement with the ADIA and the broader low risk medical device industry to support patients”.

The outcomes of ADIA’s policy advocacy are considered to be a significant policy outcome for not only businesses across the dental industry, but the broader medical devices sector. As a result of ADIA’s advocacy, when the TGA revises its fees there will be greater engagement with industry and transparency as to how these are calculated.

This update was issued on 29 June 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. .

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